Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Experimental: GSK2340272A F1 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Experimental: GSK2340272A F2 Y3-5 GROUP

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Experimental: GSK2340272A F2 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Experimental: GSK2340272A F3 Y3-5 GROUP

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Biological: GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Experimental: GSK2340272A F3 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Number of Subjects With Any Medically-attended Events (MAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]

Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within the 42-day (Days 0-41) post-vaccination period ]

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 to Month 12) ]

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

3 Years to 9 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.

Children, male or female, aged between 3 and 9 years at the time of first study vaccination.

Written informed consent obtained from the parent(s) or LAR(s) of the subject.

Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.

Clinically or virologically confirmed influenza infection within six months preceding the study start.

Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.

Have received any seasonal flu vaccine since last year.

Previous administration of any H1N1 A/California-like vaccine

Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.

History of hypersensitivity to vaccines.

History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

History of any neurological disorders or seizures.

Acute disease and/or fever at the time of enrolment:

Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.

Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.

Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.